TOLNAFTATE- medicated jock itch powder spray aerosol, powder 
Premier Brands of America Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Premier Brands Tolnaftate Jock Itch Powder Spray

Active ingredient

Tolnaftate 1%

​ ​Purpose

Antifungal

Uses

  • cures most jock itch (tinea cruris)
  • relieves itching, burning and chafing associated with jock itch

​Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF.

​When using this product

  • do not get into eyes or mouth
  • use only as directed

Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

​Stop use and ask a doctor if

  • irritation occurs
  • no improvement within 2 weeks for jock itch

​Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age. Do not use for diaper rash.

​Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • use daily for 2 weeks; if conditions persist, consult a doctor
  • in case of clogging, clear nozzle under running water

​Other information

store between 20º and 30ºC (68ºF and 86º)

​Inactive ingredient

BHT, isobutane (propellent), PPG-12-buteth-16, SD alcohol 40-B (14%w/w), talc

​Questions?

Call 1-866-964-0939

Principal Display Panel

Premier

Medicated
Jock Itch
Powder

Spray
Tolnaftate 1%

  • Cures most jock itch
  • Relieves itching, chafing & burning

NET WT 4.6 FL OZ (130g)

PB Jock Itch Tolnaftate.jpg

TOLNAFTATE 
medicated jock itch powder spray aerosol, powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-527
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1.3 g  in 130 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ISOBUTANE (UNII: BXR49TP611)  
PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
ALCOHOL (UNII: 3K9958V90M)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56104-527-53130 g in 1 CANISTER; Type 0: Not a Combination Product01/01/201312/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/201312/31/2021
Labeler - Premier Brands of America Inc. (080051232)

Revised: 1/2021
Document Id: b9be5bd7-5c9b-be91-e053-2995a90a082a
Set id: 8ca068db-07a0-4bd1-96dd-32e858473460
Version: 4
Effective Time: 20210125
 
Premier Brands of America Inc.